FDA in the Twenty-First Century : The Challenges of Regulating Drugs and New Technologies / Holly Fernandez Lynch, I. Glenn Cohen.

Format:

Book

Contributor:

Cohen, I. Glenn, editor.

Lynch, Holly Fernandez, editor.

Language:

English

Subjects (All):

United States. Food and Drug Administration.

United States.

Drugs--Law and legislation--United States.

Drugs.

Physical Description:

1 online resource (568 p.)

Other Title:

Food and Drug Administration in the twenty-first century

Place of Publication:

New York, NY : Columbia University Press, [2015]

Language Note:

English

Summary:

In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good.The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.

Contents:

Frontmatter

Contents

Acknowledgments

Introduction / Lynch, Holly Fernandez / Cohen, I. Glenn

Chapter One. Historical Themes and Developments at FDA Over the Past Fifty Years / Hutt, Peter Barton

PART ONE. FDA in a Changing World

Introduction / Lynch, Holly Fernandez

Chapter Two. A Global and Innovative Regulatory Environment for the U.S. FDA / Sklamberg, Howard / Devine, Jennifer

Chapter Three. FDA and the Rise of the Empowered Patient / Grossman, Lewis A.

Chapter Four. After the FDA / Ruger, Theodore W.

Chapter Five. The Future of Prospective Medicine Under the Food and Drug Administration Amendments Act of 2007 / Evans, Barbara J.

PART TWO. Preserving Public Trust and Demanding Accountability

Introduction / Robertson, Christopher

Chapter Six. Global Trends Toward Transparency in Participant-Level Clinical Trials Data / Digilova, Alla / Li, Rebecca / Barnes, Mark / Bierer, Barbara

Chapter Seven. Conflicts of Interest in FDA Advisory Committees / Pham-Kanter, Genevieve

Chapter Eight. The Crime of Being in Charge / Copeland, Katrice Bridges

Chapter Nine. Recalibrating Enforcement in the Biomedical Industry / O'Leary, Patrick

PART THREE. Protecting the Public Within Constitutional Limits

Introduction / Cohen, I. Glenn

Chapter Ten. Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection / Kesselheim, Aaron S. / Mello, Michelle M.

Chapter Eleven. The FDCA as the Test for Truth of Promotional Claims / Robertson, Christopher

Chapter Twelve. Why FDA's Ban on Off-Label Promotion Violates the First Amendment / Klasmeier, Coleen / Redish, Martin H.

PART FOUR. Timing Is Everything

Introduction / Price, W. Nicholson

Chapter Thirteen. Speed Versus Safety in Drug Development / Charo, R. Alta

Chapter Fourteen. Overcoming "Premarket Syndrome" / Gibson, Shannon / Lemmens, Trudo

Chapter Fifteen. FDA's Public Health Imperative / Parasidis, Efthimios

PART FIVE. Old and New Issues in Drug Regulation

Introduction / Charo, R. Alta

Chapter Sixteen. The Drug Efficacy Study and Its Manifold Legacies / Carpenter, Daniel / Greene, Jeremy / Moffitt, Susan

Chapter Seventeen. Drug Safety Communication / Levitt, Geoffrey

Chapter Eighteen. Innovation Policy Failures in the Manufacturing of Drugs / Price, W. Nicholson

PART SIX. Regulatory Exclusivities and the Regulation of Generic Drugs and Biosimilars

Introduction / Roin, Benjamin N.

Chapter Nineteen. From "Recycled Molecule" to Orphan Drug / Greenwood, Kate

Chapter Twenty. FDA, Negotiated Rulemaking, and Generics / Boyd, Marie

Chapter Twenty-One. The "Follow-On" Challenge / Rai, Arti

Chapter Twenty-Two. FDA Regulation of Biosimilars / Grabowski, Henry / Lietzan, Erika

PART SEVEN. New Wine in Old Bottles

Introduction / Miller, Frances H.

Chapter Twenty-Three. Analog Agency in a Digital World / Cortez, Nathan

Chapter Twenty-Four. Twenty-First-Century Technology with Twentieth-Century Baggage / Riley, Margaret Foster

Chapter Twenty-Five. Device-ive Maneuvers / Pike, Elizabeth R. / Spector-Bagdady, Kayte

Chapter Twenty-Six. A New Regulatory Function for E-Prescriptions / English, Andrew / Rosenberg, David / Yan, Huaou

Chapter Twenty-Seven. Race and the FDA / Kahn, Jonathan

Contributors

Index

Notes:

Description based upon print version of record.

Includes bibliographical references and index.

Description based on online resource; title from PDF title page (publisher's Web site, viewed 08. Jul 2019)

ISBN:

9780231540070

0231540078

OCLC:

918969867